Predecessor standard, successor standard, draft standard, presumption of conformity, reversal of the burden of proof? It is not always easy to find your way through the jungle of standards. Once the right standard has been found, there are also different versions available. Can the "latest" standard simply be applied - and what do the terms "presumption of conformity" and "state of the art" have to do with it? These and other questions are answered in the following technical article.
Different stakeholders are involved in the publication of European standards. The following institutions are particularly relevant for manufacturers:
The involvement of these different organisations also results in different information regarding the topicality or applicability of European standards. It is sometimes difficult for users to distinguish which status and which date means what. We will discuss this primarily using the example of EN 60204-1:2018 (Safety of machinery - Electrical equipment of machines).
The above-mentioned European standardisation organisations each consist of 34 members from the EU and EFTA states, which pursue the goal of developing European standards.
The members of these organisations are sent by the national institutes to participate in the standardisation process. Each individual national standardisation institute receives the final edition from CEN or CENELEC and generates its own national version. For example, the European document EN 60204-1:2018 becomes OVE EN 60204-1:2018-08-01 in Austria or DIN EN 60204-1:2018-06 in Germany. However, the same European version remains the basis for all national versions.
With regard to the CE process, the EU Commission is now also coming into play. EN 60204-1:2018, for example, was included by the Commission in the Official Journal of the European Union in 2020 as the successor standard to EN 60204-1:2006 for harmonised standards within the meaning of the Machinery Directive 2006/42/EC. But what does this mean?
The European Commission usually publishes various documents in the so-called "Official Journal" on a daily basis, e.g. directives, regulations, notices or court judgements, to name just a few examples. For the application of standards in conjunction with EU product directives (e.g. machinery, EMC, ATEX, pressure equipment, EMC directive, ...), publications that list "harmonised standards in support of certain directives" are particularly relevant. Those standards that are included in these lists trigger the so-called "presumption of conformity".
What this means can be seen by quoting the Machinery Directive or the Low Voltage Directive:
Machinery Directive 2006/42/EC, Art. 7 (2): Where machinery has been manufactured in conformity with a harmonised standard the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the essential health and safety requirements covered by that harmonised standard.
Low Voltage Directive 2014/35/EU, Art. 12: Electrical equipment which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the safety objectives referred to in Article 3 and Annex I covered by those standards or parts thereof.
If manufacturers design their products in accordance with harmonised standards that are listed in the Official Journal of the EU for a specific directive, they can assume that the requirements of the directive are also met in the area covered by the standard. This is referred to as "presumption of conformity" or "harmonised standards conferring presumption of conformity" or standards with "presumption of conformity" or "presumption of conformity" for short.
Source: IBF Seminar "Efficient CE marking and risk assessment of machines and plants"
The terms "harmonised standard" and "presumption of conformity" are sometimes used interchangeably. Strictly speaking, however, this is not correct, as not every harmonised standard is listed in the Official Journal of the EU and therefore not every harmonised standard gives rise to a presumption of conformity.
It is often said that the application of harmonised standards with presumption of conformity leads to a reversal of the burden of proof in favour of the manufacturer (i.e. the manufacturing company). However, this statement is too generalised from a legal perspective. Firstly, the question arises as to the situation in which a manufacturer bears the burden of proof. A distinction must be made between different situations:
Since criminal sanctions are usually directed against natural persons, this will not be discussed in detail here. However, it is important to note that in criminal proceedings, the burden of proof always and without exception lies with the state - even if a technical standard has not been met. It is simply easier to justify a breach of duty if a standard has been breached.
Proceedings before the civil courts can have very different backgrounds - such as warranty rights for material defects under sales law, claims for damages by injured parties, recourse actions by accident insurance providers and insurance companies who want to have their expenses reimbursed, or competition law proceedings by competing companies. The allocation of the burden of proof is sometimes very difficult in legal terms, but the question is not always relevant. This is because whoever has the burden of proof only loses the case if they cannot prove anything. If he can prove (for example, sufficient safety) of the product (e.g. with the help of an expert opinion), then he wins - and that is by far the majority of cases. The burden of proof therefore only has a negative effect (and ultimately not in very many cases) if you cannot sufficiently demonstrate the facts - for example because a product is so damaged in the accident that nothing can be determined.
If a market surveillance authority doubts the conformity of a product and requires the manufacturer (in case of reasonable suspicion) to prove that its product complies with the relevant laws, then - and only then - are the provisions on the presumption of conformity under product safety law applicable. The manufacturer therefore only benefits from the much-cited "reversal of the burden of proof" through the application of harmonised standards with presumption of conformity in the event of official complaints.
In other words: If a manufacturer has manufactured a product in accordance with harmonised standards with presumption of conformity, the authority must prove why it believes the product does not meet the requirements of the law (e.g. why the product does not comply with Annex I of the Machinery Directive or Annex I of the Low Voltage Directive).
It is a big myth that the benefits of presumption of conformity only apply to harmonised standards. This is true in product safety law, where official complaints are involved. But in criminal proceedings and civil proceedings for damages, case law - long before the birth of product safety law, by the way - also presumes compliance with legal requirements in the case of non-harmonised and purely national standards (DIN; ÖNORM & Co.). Conversely, the courts assume a violation of the law if a technical standard is not complied with - which the "challenged" party can refute with (good) technical arguments in favour of its solution. There are thousands of liability judgements1 on these two situations and their rare exceptions (i.e. liability despite compliance with the standard and freedom from liability despite a breach of the standard).
There is no legal regulation on this practice-relevant presumption effect of technical standards. All these court judgements are based on the civil law duty to ensure safety and the principles of the Product Liability Act (in Germany = ProdHaftG, in Austria = PHG, in Switzerland = PrHG) and the criminal law guarantor obligations with the following principles: Liability for breach of standards and exemption from liability for compliance with standards.
Footnote:1See Wilrich, Die rechtliche Bedeutung technischer Normen als Sicherheitsmaßstab - mit 33 Gerichtsurteilen zu anerkannten Regeln und Stand der Technik, Produktsicherheitsrecht und Verkehrssicherungspflichten, 2017.
When it comes to the legally regulated presumption of conformity relevant to market surveillance authorities in accordance with product safety law (see 2.1), the various organisations (see 1) now each make statements on the status of a specific document: This can be illustrated very well using the example of EN 60204-1:2018:
So there are different national editions for the same European harmonised standard. It is at the discretion of the national institute (e.g. DIN, Austrian Standards or SNV) to revise these versions, for example to correct spelling mistakes or graphics. In these cases, a new national edition may be published, which automatically withdraws the predecessor. This means that different national versions of standards may exist. However, this has no significance for the harmonised (European) standard! Harmonisation is at the discretion of the European Commission, while the creation of a European successor is at the discretion of CENELEC as the publisher of the standard.
A special case applies in every respect to standards in the EU Official Journal: even if CENELEC, as the central publisher of the standard, publishes a newer standard, the previous version is still listed in the EU Official Journal as a harmonised standard - at least until an officially announced deletion takes place in the form of an EU implementing decision and, if necessary, a successor is included. This happens again and again in practice. For users of the standard, this raises the important - and not easy to answer - question of whether a standard that is still listed in the Official Journal of the EU should still be applied, or whether it is better to apply the successor standard that is "valid" according to the manufacturer of the standard (e.g. DIN, ASI or SNV) but does not yet have a presumption of conformity.
Chronology of EN 60204-1 with the documents published for the standard. The focus here is on EN 60204-1:2018 using the example of the national publications by Austrian Standards:
The area marked in red in Figure 4 raises an important question: Should the standard EN 60204-1:2006 (with amendment and corrigendum) be applied during this period, as only this standard is listed in the Official Journal, or should the successor EN 60204-1:2018 be applied, even though there is no reference to this edition of the standard in the EU Official Journal?
In this situation, manufacturers are caught between two conflicting priorities: On the one hand, the listing of the standard in the EU Official Journal provides a certain degree of legal certainty (presumption of conformity) vis-à-vis authorities; on the other hand, the EU directives require compliance with the "state of the art" or, in civil liability law, there is even talk of the "state of the art in science and technology". Details on this can be found in a detailed article by Prof Dr Thomas Wilrich here.
In principle, it should be noted that the reversal of the burden of proof described above does not decide court proceedings, but merely reverses the burden of proof. The presumption of conformity is only a presumption and not an irrefutable fiction - and a product can be sufficiently safe even without a presumption of conformity:
All in all, the "presumption of conformity" should not be overestimated. Ultimately, the law requires compliance with the state of the art, and an "attacker" (injured party or prosecutor) could argue that the application of standards that have already been classified as "withdrawn" by the manufacturer do not (or no longer) represent the state of the art. It would not be serious to speculate on the general outcome of such legal disputes regarding the existence of sufficient or insufficient safety, as such decisions always decide on a very specific individual case and are therefore only suitable for deriving general recommendations to a limited extent. In any case, it is important that no standards are applied that have been cancelled by the Official Journal of the EU. This means that such standards are also not mentioned on the declaration of conformity. Mentioning outdated standards can lead to considerable costs due to complaints by authorities, as in the case of lawnmowers in an EGC case9.How should manufacturers now deal with such transitional periods? In principle, it is important for manufacturers not to apply the standards that are valid today, but those that will be valid at the time their products are placed on the market. Ultimately, however, it must be emphasised: The decisive factor is the state of the art at the time of placing on the market, because this is not necessarily reflected in the standard (which is, however, assumed).
This means that for more complex projects or series products in particular, it is important to check exactly how long the standards used will still be valid or what the state of the art is for each individual product delivered. This means that it can also be helpful to apply the newer standard in the time phase shown in Figure 4, as the product will only be placed on the market at a time when the old standard has already been withdrawn on the market anyway.
Unfortunately, it is not always possible to apply the newer standard in the time phase shown in Figure 4.
Unfortunately, it is not always clear when the new standard will be included in the Official Journal of the EU. This was also the case with EN 60204-1:2018, in which case it is advisable for manufacturers to check at an early stage which safety measures have been taken on products based on a standard that will soon be superseded. A comparison with the newer standard can be used to determine whether this new standard provides for any other measures at all. If the newer standard provides for other solutions that are better suited to minimising risks, these measures can and should be applied. However, it is advisable to clearly document in the risk assessment why measures deviating from the standard currently listed in the Official Journal of the EU have been taken. In Safexpert, it is therefore possible, for example, to store standard references for measures so that, in the event of changes to standards, it is possible to determine with one click which safety measures in which projects a particular standard was applied.
To summarise, this means that the selection of safety-related solutions is primarily a technical decision. In liability cases in particular (e.g. following accidents), the question arises as to whether the chosen solution has adequately reduced the risk.
Footnotes:2The EN 60204-1 standard has also been included in the Official Journal of theLow Voltage Directive 2014/35/EU in addition to the Official Journal of the Machinery Directive. However, this data is not listed here for the sake of clarity.3Swiss Federal Supreme Court, judgement of 10 April 2017 (2C_75/2016, 2C_76/2016)4VG Sigmaringen, judgement of 27 November 2008 (Ref. 8 K 1828/06) - judgement discussion no. 26 in Wilrich (footnote 1).5 EC Commission, Explanatory Notes to the Machinery Directive 1998, para. 175.6EC Commission, Explanatory Notes to the Machinery Directive 1998, para. 186.7VG Hamburg, judgement of 28 September 2010 (Ref. 10 K 1128/09) - judgement discussion no. 8 in Wilrich (footnote 1).8OLG Frankfurt, judgement of 05.07.2018 (Ref. 6 U 28/18) - Children's desk.9Online retrievable under the file number: ECLI:EU:T:2017:36
In the past, standards were usually deleted from the EU Official Journal and replaced by a successor standard with immediate effect. Since 2019, this procedure has been changed and transition periods are now usually defined for standards listed in the Official Journal of the EU. This change to the format for publishing harmonised standards in the Official Journal of the EU gives manufacturers more time to make the switch. If a successor standard is included in the Official Journal, a transitional period of approx. 2 years is usually granted, during which the old standard is still applicable for CE labelling. Taking EN 60204-1:2018 as an example, the predecessor standard EN 60204-1:2006 will remain listed for CE marking in the Official Journal of the EU until 02.10.2021 and will continue to confer a presumption of conformity until then, even though it is classified as "withdrawn" by the national standardisation organisations.
Safexpert users benefit from the fact that the various information is clearly presented by IBF employees. This is illustrated using the example of EN 15001-1, the standard for gas infrastructure gas piping systems with an operating pressure greater than 0.5 bar for industrial installations.
EN 15001:2009, for example, is listed in the EU Official Journal as a harmonised standard in accordance with the Pressure Equipment Directive at the time of publication of this article (1). However, the document has already been withdrawn by the publisher (2). The national document (3) is also marked as withdrawn.
However, CEN only communicates the withdrawal in the successor standard, EN ISO 13857:2019, which is not (yet) listed in the EU Official Journal (4), but according to the publisher CEN is currently (5), as is the national implementation, ÖNORM EN ISO 2020-07-01 (6).
Note the DOW (=date of withdrawal), which is assigned by CEN (7): this specifies the date on which national editions that conflict with the current European version must be withdrawn. The date specified here for EN ISO 13857:2019 is 15 April 2020, the date on which ÖNORM EN ISO 13857:2008-08-01 was withdrawn.
Figure 7 shows a risk assessment in Safexpert. This is filtered so that only those measures are displayed for which EN 15001-1:2009 has been applied. This filter function and the information from the Safexpert StandardsManager can be used to quickly decide whether a new standard requires different measures.
Tip: As of Safexpert 8.6 Safexpert even offers a built-in Change assistant, which makes it even easier to react to changes in standards. You can find details on this in the free technical article.
Posted on: 2020-12-17
Daniel Zacek-Gebele, MSc Product manager at IBF for additional products and data manager for updating standards data on the Safexpert Live Server. Studied economics in Passau (BSc) and Stuttgart (MSc), specialising in International Business and Economics. Email: daniel.zacek-gebele@ibf-solutions.com | www.ibf-solutions.com
Johannes Windeler-Frick, MSc ETH Member of the IBF management board. Specialist in CE marking and Safexpert. Presentations, podcasts and publications on various CE topics, in particular CE organisation and efficient CE management. Management of the further development of the Safexpert software system. Degree in electrical engineering from ETH Zurich (MSc) with a focus on energy technology and specialisation in the field of machine tools.
Email: johannes.windeler-frick@ibf-solutions.com | www.ibf-solutions.com
Prof. Dr. Thomas Wilrich Active around the topics of product safety, product liability, occupational health and safety and distribution of goods including the corresponding company organisation, contract drafting, damages and executive liability, insurance issues and criminal defence. He is responsible for business, labour, technical and corporate organisation law as well as "Law for Engineers" at the Faculty of Industrial Engineering at Munich University of Applied Sciences.
Email: info@rechtsanwalt-wilrich.de | www.rechtsanwalt-wilrich.de
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